Bring drugs to market faster, without breaking Part 11.
Tokto is the AI accountability infrastructure underneath every program, every trial, every regulatory submission, and every commercial deployment — the foundation that lets translational AI scale beyond a pilot.
An AI-assisted submission lands at the FDA. The reviewer asks how the model output was produced. The team cannot reproduce it. The submission is paused. The launch slips a quarter. The market notices.
What you get with Tokto
- Every AI capability the company ships across R&D, clinical, regulatory, manufacturing, and commercial — governed and recorded.
- A single system of record that the FDA, the EMA, OCR, the IRB, the auditor, and the board read against the same evidence.
- Policy applied at the prompt across every co-pilot, every CRO-shared model, every EMR-embedded tool, every commercial AI use.
- AI advantage at the speed of pipeline, with the audit trail the company cannot afford to be without.
How it works
Tokto is the AI operating foundation of the company. Every co-pilot, every drafting tool, every vendor AI inside R&D, clinical, regulatory, and commercial is supervised at the moment of output. The record is enterprise-owned, immutable, and queryable by program, by trial, by submission. The higher the company's AI ambitions go, the deeper this foundation has to be.
When the company wants to compress timelines with AI without an FDA integrity review, when the company wants to scale AI-assisted submissions across regions, when the company wants the board confidence to invest, the answer is one supervised control plane. The CEO ships pipeline acceleration, not Part 11 violations.
What goes wrong without it
- An AI-assisted submission stalls at the FDA over reproducibility. The launch slips. The market reads the slip.
- A vendor CRO leaks unpublished trial results through an uncontrolled AI tool. The IND is compromised.
- Class-action plaintiffs pull AI-derived adverse-event signals out of a vendor cache. The MDL is filed.
- The board freezes AI investment after two quarters of unaccounted spend. The company falls behind on AI-native competitors.
On January 6, 2025, HHS OCR proposed the first major HIPAA Security Rule update in 20 years, removing the distinction between required and addressable safeguards and tightening risk management and resilience expectations. In May 2025 the Serviceaide breach exposed PHI for 483,126 Catholic Health patients through an unsecured database. Industry research finds 83% of pharma organizations operate without basic technical controls preventing molecular structures, trial data, and PHI from leaking into public AI tools.
See how Tokto makes enterprise AI visible, governed, and accountable for CEO & Board in Life Sciences.
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